Drug Delivery Device with Needle Hub

ABSTRACT

A drug delivery device includes a housing, a fluid reservoir received within the housing, a drive assembly configured to dispense fluid from the fluid reservoir, a needle hub actuator attached to the housing, and a needle hub at least partially received by the housing. The needle hub includes a hub body, a needle holder with a needle attached to the needle holder, and a cannula holder with a cannula attached to the cannula holder. The needle hub actuator is configured to move the needle holder and the cannula holder from a retracted position where the needle and the cannula are positioned within the hub body to an insertion position where the needle and the cannula are positioned within the hub body. The needle hub is detachable from the housing.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application No.63/134,054, filed Jan. 5, 2021, which is hereby incorporated byreference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present disclosure relates to a drug delivery device with a needlehub.

Description of Related Art

Wearable medical devices, such as automatic injectors, have the benefitof providing therapy to the patient at a location remote from a clinicalfacility and/or while being worn discretely under the patient'sclothing. The wearable medical device can be applied to the patient'sskin and configured to automatically deliver a dose of a pharmaceuticalcomposition within a predetermined time period after applying thewearable medical device to the patient's skin. After the device deliversthe pharmaceutical composition to the patient, the patient maysubsequently remove and dispose of the device.

SUMMARY OF THE INVENTION

In one aspect or embodiment, a drug delivery device includes a housing,a fluid reservoir received within the housing, a drive assemblyconfigured to dispense fluid from the fluid reservoir, a needle hubactuator attached to the housing, and a needle hub at least partiallyreceived by the housing. The needle hub includes a hub body having apatient contact surface and a housing connection attaching the hub bodyto the housing, a needle holder with a needle attached to the needleholder, and a cannula holder with a cannula attached to the cannulaholder. The needle hub actuator is configured to move the needle holderand the cannula holder from a retracted position where the needle andthe cannula are positioned within the hub body to an insertion positionwhere the needle and the cannula are positioned within the hub body. Theneedle hub is detachable from the housing.

The needle hub actuator may include a needle holder connector and theneedle holder may include an actuator connector, with the needle holderconnector configured to be connected to the actuator connector. The hubbody may define a cam track and the needle holder may include a cammember received within the cam track, where axial displacement of theneedle holder is configured to rotate the needle holder to connect theneedle holder connector of the needle hub actuator to the actuatorconnector of the needle holder. The needle holder connector of theneedle hub actuator and the actuator connector of the needle holder mayform a bayonet connector.

The hub body may include a cannula lock configured to secure the cannulaholder in the insertion position. The cannula lock may include aprotrusion configured to engage the cannula holder when the cannulaholder is in the insertion position. The hub body may include a needleprotrusion configured to engage the needle holder when the needle holderis in the retracted position, and the hub body may include a cannulaprotrusion configured to engage the cannula holder when the cannulaholder is in the retracted position.

The hub body may define a cannula track and the cannula holder maydefine a track protrusion received within the cannula track, where thecannula track is linear.

The housing connection of the hub body may be received within an openingdefined by the housing. The housing connection may include a retainingmember configured to engage the housing to secure the hub body to thehousing. The housing connection may include a release member configuredto be engaged by the needle hub actuator to release the hub body fromthe housing. The retaining member and the release member may bepositioned on an extension, with the extension configured to be biasedradially outward.

The patient contact surface may include an adhesive pad configured tosecure the hub body to a skin surface of a person. The cannula holdermay include a seal engaged with the needle. The cannula holder mayinclude a port in fluid communication with the cannula, where the portof the cannula holder is in fluid communication with the fluid reservoirvia tubing. The tubing may be received within a slot defined by the hubbody. The needle holder and the cannula holder may be configured to bepositioned within the housing when the needle hub actuator moves theneedle holder and the cannula holder from the retracted position to theinsertion position.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings.

FIG. 1 is a schematic view of a drug delivery device according to oneaspect or embodiment of the present application.

FIG. 2 is a schematic view of the drug delivery device of FIG. 1.

FIG. 3 is a perspective view of a needle hub according to one aspect orembodiment of the present application.

FIG. 4A is a top view of the needle hub of FIG. 3, showing an indicatorprior to use of the needle hub.

FIG. 4B is a top view of the needle hub of FIG. 3, showing an indicatorafter insertion of a needle.

FIG. 4C is a top view of the needle hub of FIG. 3, showing an indicatorafter withdrawal of a cannula.

FIG. 5 is a schematic view showing a method of using the needle hub ofFIG. 3.

FIG. 6A is a schematic view of the needle hub of FIG. 3, showingactuation of an activation button.

FIG. 6B is a schematic view of the needle hub of FIG. 3, showingmovement of a needle and cannula from a retracted position to aninsertion position.

FIG. 6C is a schematic view of the needle hub of FIG. 3, showing aneedle in a retracted position and a cannula in an insertion position.

FIG. 6D is a schematic view of the needle hub of FIG. 3, showingmovement of a cannula to a retracted position.

FIG. 7 is a perspective view of a needle hub according to a furtheraspect or embodiment of the present application.

FIG. 8 is a front view of the needle hub of FIG. 7, showing an infusionmode.

FIG. 9 is a front view of the needle hub of FIG. 7, showing a cannulawithdrawal.

FIG. 10 is a perspective view of a needle hub according to a furtheraspect or embodiment of the present application.

FIG. 11 is a schematic view showing a method of using the needle hub ofFIG. 7.

FIG. 12A is a schematic view of the needle hub of FIG. 7, showing apre-use position of the needle hub.

FIG. 12B is a schematic view of the needle hub of FIG. 7, showing theneedle hub being actuated.

FIG. 12C is a schematic view of the needle hub of FIG. 7, showing aneedle being retracted.

FIG. 12D is a schematic view of the needle hub of FIG. 7, showing aneedle in a retracted position.

FIG. 12E is a schematic view of the needle hub of FIG. 7, showing anapplicator being detached from the needle hub.

FIG. 12F is a schematic view of the needle hub of FIG. 7, showing acannula in a retracted position.

FIG. 13 is a cross-sectional view of a needle hub according to a furtheraspect or embodiment of the present application.

FIG. 14 is a cross-sectional view of the needle hub of FIG. 13.

FIG. 15 is a perspective view of a needle hub according to a furtheraspect or embodiment of the present application.

FIG. 16 is a perspective view of a needle hub according to a furtheraspect or embodiment of the present application.

FIG. 17 is a perspective view of a needle actuation assembly accordingto one aspect or embodiment of the present application.

FIG. 18A is a cross-sectional view of the needle hub of FIG. 15, showinga cannula insertion position.

FIG. 18B is a cross-sectional view of the needle hub of FIG. 15, showinga cannula retraction position.

FIG. 19 is a perspective view of a needle hub according to a furtheraspect or embodiment of the present application.

FIG. 20 is a schematic view showing a method of using the needle hub ofFIG. 19.

FIG. 21 is a perspective view of a needle actuation assembly accordingto a further aspect or embodiment of the present application.

FIG. 22 is a perspective view of a drug delivery device and a needle hubaccording to a further aspect or embodiment of the present application.

FIG. 23 is an exploded perspective view of the drug delivery device andthe needle hub of FIG. 22.

FIG. 24 is a perspective view of the drug delivery device and the needlehub of FIG. 22, showing the drug delivery device and the needle hubconnected while delivering a medicament.

FIG. 25 is a perspective view of the drug delivery device and the needlehub of FIG. 22, showing the needle hub separated from the drug deliverydevice while delivering a medicament.

FIG. 26A is a cross-sectional view of a needle hub according to afurther aspect or embodiment of the present application, showing aninitial position of the needle hub.

FIG. 26B is a cross-sectional view of a needle hub according to afurther aspect or embodiment of the present application, showingengagement with a skin surface.

FIG. 26C is a cross-sectional view of a needle hub according to afurther aspect or embodiment of the present application, showinginsertion of a needle.

FIG. 27A is a cross-sectional view of a needle hub according to afurther aspect or embodiment of the present application, showing aninitial position of the needle hub.

FIG. 27B is a cross-sectional view of a needle hub according to afurther aspect or embodiment of the present application, showingengagement with a skin surface.

FIG. 27C is a cross-sectional view of a needle hub according to afurther aspect or embodiment of the present application, showinginsertion of a needle.

FIG. 28A is a cross-sectional view of a needle hub according to afurther aspect or embodiment of the present application, showing aninitial position of the needle hub.

FIG. 28B is a cross-sectional view of a needle hub according to afurther aspect or embodiment of the present application, showingengagement with a skin surface.

FIG. 28C is a cross-sectional view of a needle hub according to afurther aspect or embodiment of the present application, showinginsertion of a needle.

FIG. 29 is a perspective view of a needle actuation assembly accordingto a further aspect or embodiment of the present application, showing anunactuated position.

FIG. 30 is a perspective view of the needle actuation assembly of FIG.29, showing an actuated position.

FIG. 31 is a cross-sectional view of the needle actuation assembly ofFIG. 29, showing an unactuated position.

FIG. 32 is a cross-sectional view of the needle actuation assembly ofFIG. 29, showing an actuated position.

FIG. 33 is a cross-sectional view of the needle actuation assembly ofFIG. 29, showing a retracted position.

FIG. 34 is a perspective view of a needle hub according to a furtheraspect or embodiment of the present application.

FIG. 35 is a schematic view of the needle hub of FIG. 34.

FIG. 36 is a perspective view of a drug delivery device according to afurther aspect or embodiment of the present application.

FIG. 37 is a front view of the drug delivery device of FIG. 36.

FIG. 38 is a front view of the drug delivery device of FIG. 36, showinga reservoir separated from the drug delivery device.

FIG. 39 is a front view of the drug delivery device of FIG. 36, showingthe drug delivery device attached to a patient.

FIG. 40 is a partial cross-sectional view of a prior art valve assembly.

FIG. 41 is a perspective view of a drug delivery device and a needle hubaccording to a further aspect or embodiment of the present application,showing the needle hub positioned within the drug delivery device.

FIG. 42 is a perspective view of the drug delivery device and the needlehub of FIG. 41, showing the needle hub separated from the drug deliverydevice.

FIG. 43 is a perspective view of the needle hub of FIG. 41, showing aretracted position of a needle holder and a cannula holder.

FIG. 44 is a perspective view of the needle hub of FIG. 41, showing aretracted position of a needle holder and a cannula holder with aportion of the needle hub transparent for clarity.

FIG. 45 is a cross-sectional view of the needle hub of FIG. 41, showingthe needle hub being secured to a drug delivery device.

FIG. 46 is a cross-sectional view of the needle hub of FIG. 41, showingthe needle hub secured to a drug delivery device.

FIG. 47 is a partial perspective view of the needle hub of FIG. 41,showing an actuator interacting with the needle hub.

FIG. 48 is a cross-sectional view of the needle hub of FIG. 41, showinga needle holder engaged with an actuator.

FIG. 49 is a partial perspective view of the needle hub of FIG. 41,showing a needle holder engaged with an actuator with a portion of theneedle hub transparent for clarity.

FIG. 50 is a partial perspective view of the needle hub of FIG. 41,showing a needle holder displaced by an actuator with a portion of theneedle hub transparent for clarity.

FIG. 51 is a partial perspective view of a needle holder and an actuatorof the needle hub and the drug delivery device of FIG. 41.

FIG. 52 is a cross-sectional view of the needle hub of FIG. 41, showinga needle holder and a cannula holder in an insertion position.

FIG. 53 is a cross-sectional view of the needle hub of FIG. 41, showinga needle holder in a retracted position and a cannula holder in aninsertion position.

FIG. 54 is a partial front view of the needle hub of FIG. 41, showing anactuator releasing from the needle hub.

FIG. 55 is a partial perspective view of the needle hub of FIG. 41,showing an actuator releasing from a needle holder.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION OF THE INVENTION

Spatial or directional terms, such as “left”, “right”, “inner”, “outer”,“above”, “below”, and the like, are not to be considered as limiting asthe invention can assume various alternative orientations.

All numbers used in the specification and claims are to be understood asbeing modified in all instances by the term “about”. By “about” is meanta range of plus or minus ten percent of the stated value. As used in thespecification and the claims, the singular form of “a”, “an”, and “the”include plural referents unless the context clearly dictates otherwise.The terms “first”, “second”, and the like are not intended to refer toany particular order or chronology, but instead refer to differentconditions, properties, or elements. By “at least” is meant “greaterthan or equal to”.

Referring to FIGS. 1-3, a drug delivery device 10 includes a reservoir12, a power module 14, an insertion mechanism 16, control electronics18, and a housing 20. In one aspect or embodiment, the drug deliverydevice 10 is a wearable automatic injector. The drug delivery device 10may be mounted onto the skin of a patient and triggered to inject apharmaceutical composition from the reservoir 12 into the patient. Thedrug delivery device 10 may be pre-filled with the pharmaceuticalcomposition, or it may be filled with the pharmaceutical composition bythe patient or medical professional prior to use. The controlelectronics 18 may include a processor 22, such as a microcontroller, amotor driver 23, a sensing module 24, a visual driver 25, and/or audiodriver 26. The drug delivery device 10 includes a drive mechanism 27configured to dispense fluid from the reservoir 12. The drive mechanism27 may be motor powered, spring powered, hydraulic powered, pneumaticpowered, and/or other suitable drive mechanism.

The drug delivery device 10 is configured to deliver a dose of apharmaceutical composition, e.g., any desired medicament, into thepatient's body by a subcutaneous injection at a slow, controlledinjection rate. Exemplary time durations for the delivery achieved bythe drug delivery device 10 may range from about 5 minutes to about 60minutes, but are not limited to this exemplary range. Exemplary volumesof the pharmaceutical composition delivered by the drug delivery device10 may range from about 10 milliliters to about 50 milliliters, but arenot limited to this exemplary range. The volume of the pharmaceuticalcomposition delivered to the patient may be adjusted. The device 10 maycommunicate with another device, such as a mobile device or computer.

Referring to FIGS. 3-6D, according to one aspect or embodiment, theinsertion mechanism 16 includes a needle hub 30 separate from thehousing 20. The needle hub 30 includes a removal tab 32, an activationbutton 34, a status indicator 36, a finger grip, side grips, and anintegrated cannula withdrawal tab 38. The needle hub 30 includes anin-dwelling cannula. The status indicator 36 may be white when unused(FIG. 4A), blue when the needle has been inserted and ready to infuse(FIG. 4B), and green when the cannula has been withdrawn (FIG. 4C). Asshown in FIG. 5, the needle hub 30 is used by removing the packaging,removing an adhesive liner from the bottom of the needle hub 30,attaching the needle hub 30 to a skin surface, and squeezing theactivation button 34, which causes the needle to automatically retractleaving an in-dwelling cannula in the patient. The medicament or fluidis then infused into the patient. Once the infusion is complete, thecannula withdrawal tab 38 is pulled, which retracts the cannula. Theneedle hub 30 can then be removed from the skin of the patient.

Referring to FIGS. 6A-6D, in one aspect or embodiment, the needle hub 30includes a hub body 42, the activation button 34, a needle holder 44, aneedle 46 attached to the needle holder 44, a needle spring 48, acannula holder 50, a cannula 52 attached to the cannula holder 50, and acannula spring 54. The activation button 34 is moveable relative to thehub body 42 and has a first actuation surface 56. The needle holder 44is moveable relative to the hub body 42 and has a second actuationsurface 58. The first actuation surface 56 of the activation button 34is configured to engage the second actuation surface 58 of the needleholder 44. The needle spring 48 biases the needle holder 44 to aretracted position where the needle 46 is positioned within the hub body42. The cannula holder 50 is moveable relative to the hub body 42 andthe needle holder 44. The cannula 52 is configured to be in fluidcommunication with a fluid source, such as the fluid reservoir 12. Thecannula spring 54 biases the cannula holder 50 to a retracted positionwhere the cannula 52 is positioned within the hub body 42. Movement ofthe activation button 34 is configured to cause the first actuationsurface 56 of the activation button 34 to engage the second actuationsurface 58 of the needle holder 44 to move the needle holder 44 and thecannula holder 50 from the respective retracted positions to insertionpositions where distal ends of the needle 46 and the cannula 52 arepositioned outside of the hub body 42, with the needle holder 44configured to return to the retracted position while the cannula holder50 remains in the insertion position. Movement of a portion of the hubbody 42 is configured to disengage a connection between the cannulaholder 50 and the hub body 42 to allow the cannula holder 50 to returnto the retracted position.

Referring again to FIGS. 6A-6D, the needle holder 44 includes apassageway 60 configured to be in fluid communication with the fluidreservoir 12, with the needle 46 in fluid communication with thepassageway 60 of the needle holder 44. At least a portion of the needle46 is received within the cannula 52. Fluid is configured to flow fromthe fluid reservoir 12 via tubing 62 to the passageway 60 of the needleholder 44, through the needle 46, and into the cannula 52. The cannulaholder 50 includes a seal 64 engaged with the needle 46. The needle hub30 includes a first projection 66 and the cannula holder 50 includes asecond projection 68, with the first projection 66 of the needle hub 66engaging the second projection 68 of the cannula holder 50 when thecannula 52 is in the insertion position to restrict movement of thecannula holder 50 to the retracted position.

Referring to FIGS. 3-6D, the needle hub 30 includes a removal tab 70,where movement of the removal tab 70 releases an engagement between thefirst projection 66 of the needle hub 30 and the second projection 68 ofthe cannula holder 50 to allow the cannula spring 54 to bias the cannula52 to the retracted position. At least a portion of the removal tab 70is configured to be engaged with a skin surface of a person afterattaching the needle hub 30 to a person. The activation button 34 ismoveable along a first axis 72, and the needle holder 44 and the cannulaholder 50 are moveable along a second axis 74 perpendicular to the firstaxis 72. The first actuation surface 56 of the activation button 34 isconfigured to disengage from the second actuation surface 58 of theneedle holder 44 after movement of the activation button 34 apredetermined distance along the first axis 72.

Referring to FIGS. 7-14, a needle hub 80 according to a further aspector embodiment includes an applicator 82 having a needle holder 84, aneedle 86 attached to the needle holder 84, a needle retraction spring88, and an activation button 90, and a hub body 92 having a cannulaholder 94, a cannula 96 attached to the cannula holder 94, a cannulawithdrawal button 98, and a cannula retraction spring 100. At least aportion of the hub body 92 is configured to be received within theapplicator 82 and the applicator 82 is configured to be separated fromthe hub body 92. Movement of the activation button 90 is configured tomove the needle holder 84 and the cannula holder 94 from a retractedposition, where the needle 86 and the cannula 96 are positioned withinthe applicator 82 or hub body 92, to an insertion position, where distalends of the needle 86 and the cannula 96 are positioned outside of theapplicator 82 and the hub body 92. The cannula withdrawal button 98locks the cannula holder 94 in the insertion position against a biasingforce of the cannula retraction spring 100 when the cannula holder 94 ismoved from the retracted position to the insertion position. As shown inFIG. 10, in one aspect or embodiment, the cannula withdrawal button 98may be omitted.

Referring to FIGS. 12A-12F, the needle holder 84 is configured to moveto the retracted position after movement of the cannula holder 94 to theinsertion position. The activation button 90 includes an extension 102having a drive protrusion 103 and the applicator 82 includes a drivesurface 104 configured to engage the drive protrusion 103. Upon movementof the activation button 90, the drive protrusion 103 engages the needleholder 84 to move the needle holder 84 and the cannula holder 94 to theinsertion position, with the drive protrusion 103 engaging the drivesurface 104 of the applicator 82 to move the extension 102 radiallyoutward thereby releasing the needle holder 84 from the drive protrusion103 to allow the needle retraction spring 100 to return the needleholder 84 to the retracted position. Actuation of the cannula withdrawalbutton 98 is configured to move the cannula holder 94 from the insertionposition to the retracted position. The hub body 92 further includes anadhesive pad 105 configured to secure the hub body 92 to a skin surfaceof a person. The adhesive pad 105 includes a removal tab 106 extendingradially outward from the hub body 92. The activation button 90 isreceived within an opening 107 defined by a body 108 of the applicator82. The cannula holder 94 includes a port 109 configured to be in fluidcommunication with the fluid reservoir 12, with the cannula 96 in fluidcommunication with the port 109. Tubing 110 is connected to the port ofthe cannula holder 94.

Referring to FIG. 11, in one aspect or embodiment, the needle hub 80 isused by removing the packaging, removing an adhesive liner, attachingthe needle hub 80 to a skin surface of a patient and removing a safetycap, and pressing the activation button 90 of the applicator 82, whichautomatically actuates and retracts the needle 86 to leave thein-dwelling cannula 96. The applicator 82 can then be removed from thehub body 92 and the infusion can commence. Once the infusion iscomplete, the cannula withdrawal button 98 may be pressed to remove thecannula 96 from the patient, with the hub body 92 being removed from theskin of the patient using the removal tab 106.

Referring to FIGS. 13 and 14, in one aspect or embodiment, the cannulaholder 94 includes a portion of the adhesive pad 105, which removes aportion of the adhesive pad 105 from the skin of the patient when thecannula holder 94 is removed from the hub body 92 to facilitate easierremoval of the remainder of the adhesive pad 105 from the skin of thepatient.

Referring to FIGS. 15-18B, a needle hub 112, according to a furtheraspect or embodiment, includes a hub body 114, an activation button 116,a needle holder 118 and a needle 120 attached to the needle holder 118,a cannula holder 122 and a cannula 124 attached to the cannula holder122, a needle actuation mechanism 126, and a cannula spring 128. Theneedle actuation mechanism 126 is configured to move the needle holder118 and the cannula holder 122 from a retracted position to an insertionposition and is configured to move the needle holder 118 back to theretracted position. The needle actuation mechanism 126 includes a camtrack 130, a cam member 132 received within the cam track 130, and atorsion spring 134. The torsion spring 134 biases the cam member 132relative to the cam track 130. The cannula spring 128 biases the cannulaholder 122 to a retracted position. Movement of the activation button116 is configured to cause the needle holder 118 and the cannula holder122 to move from the retracted position to the insertion position, withthe needle holder 118 configured to return to the retracted positionwhile the cannula holder 122 remains in the insertion position. As shownin FIG. 16, in one aspect or embodiment, the needle hub 112 includes twolateral activation squeeze buttons 116. The needle hub 112 is used inthe same manner as described above in connection with the needle hub 30shown in FIG. 5.

Referring to FIGS. 17-18B, the hub body 114 includes a cannula lock 136configured to lock the cannula holder 122 in the insertion portion. Theneedle hub 112 includes an adhesive pad 138 configured to secure the hubbody 114 to a skin surface of a person, with the adhesive pad 138including a removal tab 140. Movement of the removal tab 140 isconfigured to disengage the cannula lock 136 and the hub body 114 toallow the cannula holder 122 to return to the retracted position. Thecannula lock 136 is biased away from the cannula holder 122 via a lockspring 142, where the hub body 112 includes a hinged portion 144, withthe hinged portion 144 configured to rotate upon movement of the removaltab 140 and disengage from the cannula lock 136. The cannula holder 122includes a port 146 configured to be in fluid communication with thefluid reservoir 12, with the cannula 124 in fluid communication with theport 146. The needle hub 112 includes tubing 148 connected to the port146 of the cannula holder 122. The cannula holder 122 includes a seal150 engaged with the needle 120, with at least a portion of the needle120 received within the cannula 124.

Referring to FIGS. 19-21, a needle hub 152, according to a furtheraspect or embodiment, includes a needle holder 154 and a needle 156attached to the needle holder 154, a needle actuation assembly 158configured to move the needle holder 154 from a retracted position, toan insertion position, and back to the retracted position, and apressure interlock 160 including an inlet 162 configured to be in fluidcommunication with the fluid reservoir 12, an outlet 164 in fluidcommunication with the needle 156, and a lock member 166. The lockmember 166 has a first position where the lock member 166 preventsactuation of the needle actuation assembly 158 and a second positionwhere the lock member 166 allows actuation of the needle actuationassembly 158. The lock member 166 is moved from the first position tothe second position based on a pressure within the pressure interlock160.

Referring to FIG. 21, the lock member 166 isolates the inlet 162 fromthe outlet 164 when the lock member 166 is in the first position, andthe lock member 166 allows fluid communication between the inlet 162 andthe outlet 164 when the lock member 166 is in the second position. Theneedle hub 152 further includes tubing 168 connected to the outlet 164and in fluid communication with the needle 156. The lock member 166includes an opening 170, with a portion of the needle actuation assembly158 extending through the opening 170 of the lock member 166 when thelock member 166 is in the second position. The needle actuation assembly158 includes a cam track 172, a cam member 174, and an actuation spring176 biasing the cam member 174 relative to the cam track 172. A camblock 178 defines the cam track 172, with the cam block 178 extendingthrough the opening 170 of the lock member 166 when the lock member 166is in the second position. The needle actuation assembly 158 furtherincludes a cannula 180, where the needle 156 is received within thecannula 180 when the needle holder 156 is in the retracted position.

Referring again to FIGS. 19-21, the needle hub 152 includes a housing182 and a removal tab 184. A top surface 186 of the housing 182 issmooth and free of activation buttons. As shown in FIG. 20, the needlehub 152 is used by removing packaging, removing an adhesive liner,attaching the needle hub 152 to a skin surface of a patient, andactivating the drive mechanism 27 to insert the needle 156, with theneedle 156 automatically retracting leaving the in-dwelling cannula 180.After infusion is complete, the needle hub 152 is removed by graspingthe removal tab 184 and lifting upwards, with the cannula 180automatically retracting. In one aspect or embodiment, pulling theremoval tab 184 causes a drop in pressure of the pressure interlock 160to cause the cannula holder and/or the cannula 180 to automaticallyretract.

Referring to FIGS. 22-25, a drug delivery device 190 and a needle hub192, according to a further aspect or embodiment, is shown. The drugdelivery device 190 may be similar to the drug delivery device 10 shownin FIGS. 1 and 2. The drug delivery device 190 and the needle hub 192 ofFIGS. 22-25, however, is modular, with the needle hub 192 optionallyintegrated within the drug delivery device 190 (FIG. 24) or with theneedle hub 192 separated from the drug delivery device 190 andseparately attached to a skin surface of a patient (FIG. 25). In oneaspect or embodiment, the drug delivery device 190 and the needle hub192 may remain connected or integral for lower drug volume and separatedwith a fluid connection therebetween for larger drug volumes.

Referring to FIGS. 26A-26C, a needle hub 200 with a skin tentingreduction feature, according to one aspect or embodiment, is shown. Theneedle hub 200 includes a rotating engagement mechanism 202, with aportion of the rotating engagement mechanism 202 first contacting a skinsurface of the patient and adhering to the skin surface and furtherrotating as the needle hub 200 is fully pressed onto the skin surface.The initial adherence and further rotation of the rotating engagementmechanism stretches the skin to reduce skin tenting.

Referring to FIGS. 27A-27C, a needle hub 204 with a skin tentingreduction feature according to one aspect or embodiment is shown. Theneedle hub 204 includes an adhesive ring 206 that is pressed onto theskin prior to insertion of a needle when an activation button isdepressed or actuated. The adhesive ring 206 stretches the skin toreduce skin tenting.

Referring to FIGS. 28A-28C, a needle hub 208 with a skin tentingreduction feature according to one aspect or embodiment is shown. Theneedle hub 208 includes skin stretching member 210 that is movedradially outward after being initially adhered to a skin surface of apatient. An activation button 212 engages the skin stretching member 210to move the skin stretching member 210 radially outward, which stretchesthe skin locally to reduce skin tenting.

The skin tenting reduction features and associated mechanisms of FIGS.26A-28C may be incorporated into any of the aspect or embodiments of theneedle hub or needle insertion arrangements disclosed herein.

Referring to FIGS. 29-33, a needle actuation assembly 220, according toone aspect or embodiment, includes a clip 222 that holds a needleactuator body 224 and cannula body 226 in the retracted position, whichare biased by a spring 228. Pushing the clip 222 inwards releases theneedle actuator body 224 and cannula body 226 to cause insertion of aneedle 230 and a cannula 232. When the cannula body 226 reaches thebottom of a housing 233, the cannula body 226 contacts angled featurescausing the cannula body 226 to rotate and/or twist. The cannula body226 is held down by clips 236 in the walls of the housing 233. After thecannula body 226 rotates and/or twists, the needle actuator body 224 isreleased and a return spring 238 retracts the needle 230.

Referring to FIGS. 34 and 35, a needle hub 240 according to a furtheraspect or embodiment is configured to be decoupled from remainingcomponents of a drug delivery device. The needle hub 240 includes aprotective cap 242, a needle insertion mechanism 244, connectionarrangement 246 configured to place the needle hub 240 in fluidcommunication with the reservoir 12 and the drive mechanism 27, a fluidpath 248, and an adhesive pad and/or layer 250. The connectionarrangement 246 may provide for aseptic connection between the needlehub 240 and the reservoir 12. The needle retraction may be manuallyactivated or automatically activated via a triggering mechanismconnected to an end of dose event and/or a wireless connection betweenthe driving unit and the needle hub 240. The triggering mechanism mayinclude a flexible rigid connection to plunger rod movement (totally orpartially at the end of translation). The fluid path 248 and connectionarrangement 246 is maintained sterile until the connection isestablished, with sterilization of the sub-system and reservoir.

Referring to FIGS. 36-39, a drug delivery device 252, according to afurther aspect or embodiment, includes a flexible reservoir 254, with atleast a portion of the flexible reservoir 254 positioned externally froma remaining portion of the drug delivery device 252. The drug deliverydevice 252 may be similar to the drug delivery device 10 shown in FIGS.1 and 2. As shown in FIG. 39, for smaller volumes, such as 10 mL-30 mL,the flexible reservoir 254 may be directly attached to the drug deliverydevice 252 and worn on a skin surface of the patient. As shown in FIG.38, for larger volumes, such as 50 mL, the flexible reservoir 254 may beseparated from the drug delivery device 252 and fluidly connected to thedrug delivery device 252 via a fluid path 256, such as a tube. Theflexible reservoir 254 may be separately attached to the patient via abelt clip, harness, strap, or other suitable arrangement.

Referring to FIG. 40, the drug delivery devices in any of the aspects orembodiments discussed above may utilize a valve assembly 260 thatengages a reservoir and/or container to facilitate the fluid connectionbetween the reservoir and/or container and the fluid path to the needleand/or cannula. The valve assembly 260 may be similar to and operate inthe same manner as the valve assembly shown and described in U.S. PatentApplication Publication No. 2017/0354788.

Referring to FIGS. 41-55, a drug delivery device 270 and a needle hub272, according to a further aspect or embodiment, is shown. The drugdelivery device 270 may be similar to the drug delivery device 10 shownin FIGS. 1 and 2. In one aspect or embodiment, the drug delivery device270 includes the housing 20, the fluid reservoir 12 received within thehousing 20, and the drive mechanism 27 configured to dispense fluid fromthe fluid reservoir 12. The drug delivery device 270 further includes aneedle hub actuator 274 attached to the housing 20. The needle hub 272is at least partially received by the housing 20. The needle hub 272includes a hub body 276 having a patient contact surface 278 and ahousing connection 280 attaching the hub body 276 to the housing 20, aneedle holder 282 with a needle 284 attached to the needle holder 282,and a cannula holder 286 with a cannula 288 attached to the cannulaholder 286. The needle hub actuator 274 is configured to move the needleholder 282 and the cannula holder 286 from a retracted position wherethe needle 284 and the cannula 288 are positioned within the hub body276 to an insertion position where the needle 284 and the cannula 288are positioned within the hub body 276. The needle hub 272 is detachablefrom the housing 20.

Referring to FIGS. 43-55, the needle hub actuator 274 includes a needleholder connector 290 and the needle holder 282 includes an actuatorconnector 292, with the needle holder connector 290 configured to beconnected to the actuator connector 292. The hub body 276 defines a camtrack 294 and the needle holder 282 includes a cam member 296 receivedwithin the cam track 294. Axial displacement of the needle holder 282 isconfigured to rotate the needle holder 282 to connect the needle holderconnector 290 of the needle hub actuator 274 to the actuator connector292 of the needle holder 282. As shown more clearly in FIGS. 49-51, theneedle holder connector 290 of the needle hub actuator 274 and theactuator connector 292 of the needle holder 282 form a bayonetconnector, although other suitable connection arrangements may beutilized. As shown in FIGS. 52 and 53, the hub body 276 includes acannula lock 298 configured to secure the cannula holder 286 in theinsertion position. In one aspect or embodiment, the cannula lock 298 isprotrusion received by a corresponding recess of the cannula holder 286,although other suitable arrangements may be utilized. As shown in FIGS.48, 52, and 53, the hub body 276 includes a needle protrusion 300configured to engage the needle holder 282 when the needle holder 282 isin the retracted position, and the hub body 276 includes a cannulaprotrusion 302 configured to engage the cannula holder 286 when thecannula holder 286 is in the retracted position.

Referring again to FIGS. 41-55, the hub body 276 defines a cannula track304 and the cannula holder 286 includes a track protrusion 306 receivedwithin the cannula track 304. The cannula track 304 is linear, whichcorresponds to the linear, non-rotating movement of the cannula holder286 between the retracted position and the insertion position. As shownmore clearly in FIG. 47, the housing connection 280 of the hub body 276is received within an opening 308 defined by the housing 20. The housingconnection 280 includes a retaining member 310 configured to engage thehousing 20 to secure the hub body 276 to the housing 20. The housingconnection 280 also includes a release member 312 configured to beengaged by the needle hub actuator 274 to release the hub body 276 fromthe housing 20. The retaining member 310 and the release member 312 arepositioned on an extension 314, with the extension 314 configured to bebiased radially outward. The patient contact surface 278 includes anadhesive pad 316 configured to secure the hub body 276 to a skin surfaceof a person. The cannula holder 286 includes a seal 318 engaged with theneedle 284. The cannula holder 286 includes a port 320 in fluidcommunication with the cannula 288. The port 320 of the cannula holder286 is in fluid communication with the fluid reservoir via tubing 322.The tubing 322 is received within a slot 324 defined by the hub body276.

Referring again to FIGS. 43-55, at the time of assembly orpost-assembly, the needle hub 272 is connected to the housing 20 of thedrug delivery device 270 by inserting the retaining member 310 into theopening 308. The needle hub 272 is attached to a skin surface of aperson by placing the needle hub 272, while attached to the drugdelivery device 270, onto a skin surface and actuating the needle hubactuator 274. The needle hub actuator 274 is linearly or axiallymoveable relative to the drug delivery device 270. The needle hubactuator 274 may be driven by an electric motor, hydraulics, pneumatics,or other suitable arrangement. During initial movement of the needle hubactuator 274, the needle hub actuator 274 engages and axially moves theneedle holder 282, which causes the needle holder 282 to rotate due tothe cam member 296 moving through a curved portion of the cam track 294.The rotation of the needle holder 282 connects the needle hub actuator274 to the needle holder 282 via the needle holder connector 290 and theactuator connector 292.

The needle hub actuator 274 continues to move axially to move the needleholder 282 and the cannula holder 286 to the insertion position (FIG.52). The needle hub actuator 274 retracts with the needle holder 282still secured to the needle hub actuator 274 thereby moving the needleholder 282 back to the retracted position. The cannula holder 286remains in the insertion position due to the cannula lock 298 engagingthe cannula holder 286. As the needle hub actuator 274 and the needleholder 282 reach their initial position, the needle holder 282 rotatesagain to the initial position of the needle holder 282, which releasesthe needle hub actuator 274 from the needle holder 282. As the needlehub actuator 274 is fully retracted, the needle hub actuator 274 engagesthe release member 312 of the housing connection 280 to deflect thehousing connection 280 radially outward thereby releasing the needle hub272 from the drug delivery device 270 to allow the drug delivery device270 to be separated from the needle hub 272. The drug delivery device270 can then infuse medication from the fluid reservoir 12, through thetubing 322, through the cannula 288, and into a patient.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

The invention claimed is:
 1. A drug delivery device comprising: ahousing; a fluid reservoir received within the housing; a drive assemblyconfigured to dispense fluid from the fluid reservoir; a needle hubactuator attached to the housing; and a needle hub at least partiallyreceived by the housing, the needle hub comprising: a hub bodycomprising a patient contact surface and a housing connection attachingthe hub body to the housing; a needle holder with a needle attached tothe needle holder; and a cannula holder with a cannula attached to thecannula holder, wherein the needle hub actuator is configured to movethe needle holder and the cannula holder from a retracted position wherethe needle and the cannula are positioned within the hub body to aninsertion position where the needle and the cannula are positionedwithin the hub body, and wherein the needle hub is detachable from thehousing.
 2. The drug delivery device of claim 1, wherein the needle hubactuator comprises a needle holder connector and the needle holdercomprises an actuator connector, the needle holder connector configuredto be connected to the actuator connector.
 3. The drug delivery deviceof claim 2, wherein the hub body defines a cam track and the needleholder comprises a cam member received within the cam track, and whereinaxial displacement of the needle holder is configured to rotate theneedle holder to connect the needle holder connector of the needle hubactuator to the actuator connector of the needle holder.
 4. The drugdelivery device of claim 3, wherein the needle holder connector of theneedle hub actuator and the actuator connector of the needle holder forma bayonet connector.
 5. The drug delivery device of claim 4, wherein thehub body comprises a cannula lock configured to secure the cannulaholder in the insertion position.
 6. The drug delivery device of claim5, wherein the cannula lock comprises a protrusion configured to engagethe cannula holder when the cannula holder is in the insertion position.7. The drug delivery device of claim 3, wherein the hub body comprises aneedle protrusion configured to engage the needle holder when the needleholder is in the retracted position, and wherein the hub body comprisesa cannula protrusion configured to engage the cannula holder when thecannula holder is in the retracted position.
 8. The drug delivery deviceof claim 3, wherein the hub body defines a cannula track and the cannulaholder comprises a track protrusion received within the cannula track,and wherein the cannula track is linear.
 9. The drug delivery device ofclaim 1, wherein the housing connection of the hub body is receivedwithin an opening defined by the housing.
 10. The drug delivery deviceof claim 9, wherein the housing connection comprises a retaining memberconfigured to engage the housing to secure the hub body to the housing,and wherein the housing connection comprises a release member configuredto be engaged by the needle hub actuator to release the hub body fromthe housing.
 11. The drug delivery device of claim 10, wherein theretaining member and the release member are positioned on an extension,the extension configured to be biased radially outward.
 12. The drugdelivery device of claim 1, wherein the patient contact surfacecomprises an adhesive pad configured to secure the hub body to a skinsurface of a person.
 13. The drug delivery device of claim 1, whereinthe cannula holder comprises a seal engaged with the needle.
 14. Thedrug delivery device of claim 13, wherein the cannula holder comprises aport in fluid communication with the cannula, and wherein the port ofthe cannula holder is in fluid communication with the fluid reservoirvia tubing.
 15. The drug delivery device of claim 14, wherein the tubingis received within a slot defined by the hub body.
 16. The drug deliverydevice of claim 1, wherein the needle holder and the cannula holder areconfigured to be positioned within the housing when the needle hubactuator moves the needle holder and the cannula holder from theretracted position to the insertion position.